Editor’s Remarks to FDA Committee on Peanut Allergy Drug

in Food Allergy, Food Allergy News
Published: September 16, 2019
Photo: Getty

Allergic Living’s Gwen Smith presented the following statement on Sept. 13, 2019 to the FDA’s Allergenic Products Advisory Committee, which was reviewing the license application for the first peanut OIT therapy.

I’m Gwen Smith, co-owner and editor of Allergic Living, a national digital magazine and website. I’m here today representing an audience of almost 2 million Americans with food allergies. Plus, I speak as someone who lives with severe food allergies, including peanut. 

I’ve seen news reports describe Aimmune’s AR101 as “not a cure” for peanut allergy – but “simply” a desensitization therapy.

Let’s consider desensitization – what it means to the food allergy community, and why there is no ‘simply’ about it.

Severe anaphylaxis feels like … drowning without water. You can’t get your breath – and it’s terrifying. That’s the symptom that stands out to most of us. I know it first-hand.

To the parents I deal with, the very idea that your child could be protected against that – this is huge.

Desensitization means being freed from having to think that any tiny, wrong bite could potentially kill. That is life-changing. A whole family can breathe again.

Fears and Avoidance

The AR101 protocol shouldn’t be judged against a cure, which is elusive, but against the status quo of allergen avoidance.

Consider this:
• In a 2018 paper, Mount Sinai allergists Sicherer and Sampson wrote that “the emotional effect of living with food allergies cannot be under-estimated.” This is the avoidance status quo.

• A recent survey from the Asthma and Allergy Foundation of America finds 75% of this community consumed by food allergy anxiety.

• So widespread is food allergy anxiety that psychologists now specialize in the area.

• I have reported on those who’ve suffered PTSD following their children’s severe reactions, such as the California mother who for a year burst into tears at the sound of sirens. A psychologist told me: “I hear stories like hers all the time.”

The big fear is that anaphylaxis, even to trace exposures, can be fatal. While every, single one cuts deep, such tragedies fortunately are not common.

However, severe reactions are common. A 2017 analysis of health insurance claims found emergency treatment of anaphylaxis spiked 377 percent in a decade. The biggest individual food trigger? Peanut.

I hear it regularly: OIT improves quality of life. It’s not surprising that a new follow-up study from the Aimmune trial shows exactly this.

Patience Wears Thin
Gwen Smith speaks at the FDA panel hearing.

Think of our food allergy families. For years, they have been told: OIT is not ready. Wait for the double-blind studies to see if a protocol can prove effective and safe.

There was a two-thirds success rate in the AR101 clinical trial, and many families now want this therapy – to protect their children.

It’s not perfect: there are adverse effects in the buildup phase – but many families are prepared for some symptoms for long-term peace of mind.

If the FDA approves AR101, many allergists would offer the therapy. They’d like to offer more than just avoidance.

When I reported on an OIT study analysis that favored ‘allergen avoidance’ over OIT, many parents were shocked by this. In their view: Avoidance alone is no longer enough.

The demand for food allergy treatment is here. An anxiety-plagued community grows tired of waiting.

My hope is that FDA-approved OIT would be just the start of emerging treatments for food allergy. It would be wonderful to see much-improved quality of life for those managing food allergies. Thank you for letting me speak on behalf of my community.

Related: Expert Panel Backs FDA Approval of Aimmune’s Peanut OIT Drug